ReactTMRecalls & reported problems across all models

We found 2 models of ReactTM by Micro Therapeutics, Inc. in the FDA's device registry (GUDID). Together they are named in 31 adverse event reports in the FDA's MAUDE database, received between Nov 14, 2018 and Sep 10, 2026 — classified as 2 deaths, 12 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Break” (15 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported ReactTM problems

ReactTM models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ReactTM REACT-71

  Catheter, percutaneous
  19 reports
• ReactTM REACT-68

  Catheter, percutaneous
  2 deaths12 reports

Recent ReactTM adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Break; Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50715909 ↗
• MalfunctionMar 19, 2026Break

  MEDTRONIC RECEIVED A REPORT THAT THE IN THE EARLY MORNING OF (B)(6), THE REPORTED HOSPITAL PERFORMED A MIDDLE CEREBRAL ARTERY M2 SEGMENT THROMBECTOMY. DURING ADVANCEMENT OF THE DISTAL ACCESS CATHETER TO THE PROXIMAL SEGMENT OF THE MIDDLE CEREBRAL ARTERY THROMBUS USING A MICRO GUIDEWIRE AND MICROCATHETER COAXIAL TECHNIQUE, THE DISTAL ACCESS CATHETER WAS NOT SHAPED, AND ASPIRATION WITH A 50 ML SYRINGE SHOWED AIR REFLUX AND INABILITY TO MAINTAIN NEGATIVE PRESSURE. THE CATHETER WAS REMOVED FOR INSPECTION, AND A RUPTURE WAS FOUND AT THE TIP END. A NEW REACT-71 WAS USED INSTEAD FOR ASPIRATION, SUCCESSFUL RECANALIZATION WAS ACHIEVED IN A SINGLE PASS, THE PATIENT WAS IN GOOD CONDITION, AND THE PROCEDURE WAS COMPLETED. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24639873 ↗
• MalfunctionSep 4, 2025Material Deformation; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT AFTER ANGIOGRAPHY, THE PATIENT WAS SUSPECTED OF ACUTE OCCLUSION OF THE LEFT INTERNAL CAROTID ARTERY. THE SURGEON CONSIDERED USING A DISPOSABLE INTRACRANIAL THROMBUS ASPIRATION CATHETER REACT-71 + THROMBECTOMY STENT TO PERFORM SWIM THROMBECTOMY FOR THE PATIENT. UNDER THE GUIDANCE OF THE MICROCATHETER REBAR-18 AND THE GUIDEWIRE AVIGO, REACT-71 SUCCESSFULLY REACHED THE PROXIMAL END OF THE OCCLUDED LESION SEGMENT, AND THE SOLITAIREX INTRACRANIAL THROMBECTOMY STENT SFR4-6-40-10 WAS SELECTED FOR IMPLANTATION. AFTER THE STENT WAS OPENED AND OBSERVED FOR 5 MINUTES, THE FIRST STENT THROMBECTOMY WAS PERFORMED UNDER THE CONTINUOUS NEGATIVE PRESSURE OF THE 20ML SYRINGE. WHEN THE REACT-71 AND THE THROMBECTOMY STENT WERE WITHDRAWN FROM THE BODY, THE SURGEON FOUND THAT THE TIP OF THE REACT-71 CATHETER WAS OBVIOUSLY NARROWED AND DEFLATED AT ABOUT 1.5CM, AND THE ENTIRE TIP OF THE CATHETER WAS NOT SMOOTH. CONSIDERING THE SAFETY OF THE SUBSEQUENT OPERATION, THE SURGEON IMMEDIATELY REPLACED THE CATHETER WITH ANOTHER REACT-71 CATHETER FOR THE SUBSEQUENT OPERATION AND REQUESTED THAT THE FIRST REACT-71 BE COMPLAINED ABOUT WITHOUT CHARGE. AFTER THE OPERATION W AS SUCCESSFU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22968357 ↗
• MalfunctionJul 14, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD OCCLUSION AT THE END OF THE INTERNAL NECK ARTERY. THE SURGEON USED A MICRO-GUIDEWIRE AND MICRO-CATHETER WITH REACT71 IN PLACE TO ASPIRATE ONCE BUT FAILED. THEN THE SURGEON PREPARED THE SFR-6-30 STENT FOR THROMBECTOMY. DURING THE STENT DELIVERY PROCESS, THE SURGEON COULD NOT PUSH IT OUT OF THE MICRO-CATHETER. AFTER SEVERAL ATTEMPTS TO PUSH THE IT OUT, IT FAILED. AFTER PULLING IT OUT, IT WAS FOUND THAT THE PUSH GUIDEWIRE AT THE TIP WAS DAMAGED AND COULD NOT BE USED ANYMORE. THE RESISTANCE WAS IN THE DISTAL SECTION OF THE CATHETER. CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE GUIDEWIRE WAS AN AVIGO. THERE WAS NO DAMAGE TO THE REACT CATHETER. ANCILLARY DEVICES: AVIGO GUIDEWIRE MODEL: 103-0606-200 LOT NO.: B812571.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 22496222 ↗
• InjuryJul 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED. PATIENT SUFFERED A COMPLETED INFARCT. PER THE PHYSICIAN, HE DOES NOT BELIEVE THAT IT WAS DUE TO THE CATHETER TIP THAT WAS LEFT BEHIND. THERE WAS NO ADDED DEFICIT SECONDARY TO THE CATHETER TIP. NO ACTIONS/INTERVENTIONS WERE TAKEN TO RESOLVE THE CATHETER TIP LEFT IN PATIENT AND STROKE.

  Patient problems: Foreign Body In Patient; Ischemia; Ischemia Stroke

  MAUDE report 19751858 ↗
• MalfunctionNov 14, 2022Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE SOLITAIRE 4/40 WAS PLACED IN THE M2 REGION OF THE PATIENT. THE REACT 68 WAS ADVANCED OVER SOLITAIRE WIRE INTO THE M2 REGION TO ENGAGE CLOT. BOTH DEVICES WERE REMOVED TOGETHER UNDER SUCTION. THE PHYSICIAN NOTICED THE SOLITAIRE HAD BEEN TWISTED INSIDE REACT BUT OTHERWISE WAS INTACT. A SECOND PASS WAS ATTEMPTED WITH THE SAME REACT 68 BUT A NEW SOLITAIRE 4/40. THE SAME POSITION IN THE M2 WAS ACHIEVED. THE PHYSICIAN AGAIN REMOVED BOTH DEVICES. TICI 3 WAS ACHIEVED BUT THE PHYSICIAN NOTICED THE DISTAL END OF THE REACT WAS COMPROMISED. THE PHYSICIAN CONFIRMED THERE WERE NO CATHETER FRAGMENTS IN PATIENT AND ENDED THE CASE. CATHETER SEPARATION/BREAK OCCURRED IN THE DISTAL SECTION DURING USE. THERE WAS NO FRICTION OR DIFFICULTY DURING INJECTION. THERE WAS NO FORCE APPLIED DURING DELIVERY OR REMOVAL.  THE CATHETER TIP WAS NOT ENTRAPPED/STUCK. THERE WAS NO VASOSPASM. THE CATHETER WAS NOT STUCK INSIDE THE GUIDE CATHETER. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. BROKEN SEGMENTS WERE REMOVED FROM THE PATIENT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. NO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15788833 ↗
• MalfunctionNov 7, 2022Leak/Splash; Difficult to Advance; Physical Resistance/Sticking; Leak/Splash; Difficult to Advance; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CATHETER WAS NOT PUNCTURED BY AN INTRALUMINAL DEVICE, AND THE INTERNAL CONSUMABLES PASSED NORMALLY. A .088" HEMO LONG SHEATH HAD RESISTANCE IN THE REACT CATHETER. A TRACLINE CATHETER WAS ALSO USED. ACCORDING TO THE INTRAOPERATIVE SITUATION, THE PRELIMINARY JUDGMENT WAS CAUSED BY THE LARGE TORTUOSITY OF THE BLOOD VESSELS, THE HIGH TENSION OF THE CATHETER, AND THE INCREASED FRICTION WITH THE EXTERNAL HEMO LONG SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15744370 ↗
• DeathOct 19, 2022Break; Device Dislodged or Dislocated; Physical Resistance/Sticking; Break; Device Dislodged or Dislocated; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE DISTAL TIP OF THE REACT 68 CATHETER BROKE OFF AFTER 2 PULLS OF THE SOLITAIRE AND LODGED IN THE VESSEL. ATTEMPTS TO RETRIEVE IT WERE UNSUCCESSFUL. THE PATIENT INCURRED A BRAIN BLEED DURING THE PROCEDURE AND LATER DIED. THE PATIENT WAS UNDERGOING A MECHANICAL THROMBECTOMY FOR A STROKE. THE ACCESS VESSEL WAS THE FEMORAL ARTERY. IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED DURING THE PROCEDURE. THE DEVICE WAS REMOVED, AND THE TIP OF THE CATHETER WAS FRACTURED. SUBSEQUENT CEREBRAL ANGIOGRAPHY AND FLUOROSCOPY LOCATED THE TIP OF THE CATHETER IN THE LEFT INTERNAL CAROTID ARTERY BIFURCATION. AFTER ATTEMPTS TO REMOVE THE TIP WERE UNSUCCESSFUL, CT IMAGING SHOWED INCREASING CONSPICUITY IN THE VERY LARGE ACUTE LEFT MIDDLE CEREBRAL ARTERY AND MODERATE ACUTE ANTERIOR DIVISION LEFT ANTERIOR CEREBRAL ARTERY DISTRIBUTION INFARCT. THERE WAS HEMORRHAGIC CONVERSION WITH MODERATE TO LARGE ACUTE HEMATOMA CENTERED ON THE LEFT BASAL GANGLIA/INTERNAL CAPSULE AND INSULA WITH MILD SUBARACHNOID HEMORRHAGE ALONG THE LEFT SYLVAN FISSURE. THERE WAS MODERATE INTERVAL INCREASE IN MASS EFFECT WITH INCREASING LEFT-TO-RIGHT MIDLINE SHIFT FROM 3 TO 8MM. HEALTH EFFECTS INCLUDED HE

  Patient problems: Device Embedded In Tissue or Plaque; Hematoma; Intracranial Hemorrhage; Obstruction/Occlusion; Perforation of Vessels

  MAUDE report 15636703 ↗
• MalfunctionAug 18, 2022Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE REACT 68 CATHETER BROKE. THE PATIENT WAS UNDERGOING TREATMENT FOR ACUTE ISCHEMIC STROKE. THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE ACCESS VESSEL WAS THE RIGHT ICA, WHICH WAS 4.5MM IN DIAMETER. IT WAS REPORTED THAT THE PATIENT UNDERWENT A THROMBECTOMY AND MANUAL SUCTION WAS PERFORMED USING A SYRINGE. THE PROXIMAL PART OF REACT 68 CATHETER BROKE WHILE REMOVING THE ENTIRE SYSTEM. AS A RESULT, THE DOCTOR HAD TO USE A DIFFERENT REACT WHEN PERFORMING ASPIRATION ONCE MORE. THERE WAS NO FRICTION/DIFFICULTY DURING INJECTION, NO FOR WAS WAS APPLIED DURING DELIVERY OR REMOVAL, THE CATHETER TIP WAS NOT ENTRAPPED/STUCK, THERE WAS NO VASOSPASM, THE CATHETER WAS NOT STUCK INSIDE THE GUIDE CATHETER, AND NO ADDITIONAL MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT DID NOT EXPERIENCE ANY INJURY. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A FLOWGATE 8F GUIDE CATHETER AND A PHENOM 21 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15251494 ↗
• InjuryJun 10, 2022Break; Difficult to Remove; Device Dislodged or Dislocated; Break; Difficult to Remove; Device Dislodged or Dislocated

  MEDTRONIC RECEIVED A REPORT THAT THE REACT-68 DISTAL MARKER WAS SEPARATED DURING THE 3RD PASS WITH THE SOLITAIRE 4X40 AT THE M1/M1 B IFURCATION WHICH WAS THE LOCATION OF THE CLOT. THE DISTAL MARKER DISK WAS CONFIRMED IN THE VESSEL USING FLUOROSCOPY. AN ADDITIONAL SOLITAIRE 4X40 WAS USED TO MAKE 3 MORE PASSES TO FISH THE DISTAL MARKER DISK OUT OF THE PATIENT USING ANOTHER REACT-68 AND CELLO. THE SYSTEM WAS REMOVED TO CONCLUDE THE CATHETER. THERE WAS NO FORCE APPLIED DURING DELIVERY OR REMOVAL. THE CATHETER TIP WAS ENTRAPPED/STUCK. THERE WAS NO VASOSPASM AND THE CATHETER WAS NOT STUCK INSIDE THE GUIDE CATHETER. SURGICAL OR MEDICINAL INTERVENTION WAS REQUIRED. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING TREATMENT FOR AN ACUTE ISCHEMIC STROKE. THE PATIENT HAD MODERATE VESSEL TORTUOSITY. ANCILLARY DEVICES INCLUDE: CELLO9FR SHEATH, REACT-68 GUIDE CATHETER, MARKSMAN MICROCATHETER, AND ASAHI CHICKAI GUIDEWIRE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14652668 ↗
• MalfunctionDec 3, 2021Stretched; Device Dislodged or Dislocated; Physical Resistance/Sticking; Stretched; Device Dislodged or Dislocated; Physical Resistance/Sticking

  MEDTRONIC RECEIVED REPORT THAT THE PHYSICIAN EXPERIENCED STRETCHING AS THE REACT-71 CATHETER WAS REMOVED FROM THE RHV WHEN COMPLETING RETRIEVAL. IT WAS NOTED THAT THERE HAD BEEN CATHETER RESISTANCE IN THE MIDDLE SEGMENT AND THE MARKER BAND WAS DISLODGED AND REMAINED IN THE PATIENT. IT WAS NOTED THE DEVICE WAS PREPARED AS FLUSHED PER THE IFU. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT. THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE TO TREAT STROKE IN A MIDDLE CEREBRAL ARTERY (MCA).

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12924484 ↗
• InjuryAug 23, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO ISSUES THAT LED TO THE MARKER BAND DISLODGEMENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12356025 ↗
• InjuryJul 22, 2021Device Dislodged or Dislocated; Material Deformation; Physical Resistance/Sticking; Device Dislodged or Dislocated; Material Deformation; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2021. THERE WAS NO PLAN TO REMOVE THE MARKER BAND IN THE FUTURE. NOTHING WAS DONE TO SECURE THE DISLODGED MARKER BAND WITHIN THE VESSEL.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12211545 ↗
• InjuryApr 1, 2021Stretched; Deformation Due to Compressive Stress; Device Damaged by Another Device; Physical Resistance/Sticking; Stretched; Deformation Due to Compressive Stress; Device Damaged by Another Device; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT IT WAS UNCLEAR IF THE DISSECTION WAS CAUSED BY THE DEVICE, USER/TECHNIQUE ERROR, OR IF IT WAS PRE-EXISTING. THE DEVICES WERE PREPARED ACCORDING THE INSTRUCTIONS FOR USE (IFU). AS OF 26-MAR-2021 THE PATIENT WAS ALIVE AND STABLE.

  Patient problems: Vascular Dissection

  MAUDE report 11606682 ↗
• InjuryApr 1, 2021Stretched; Deformation Due to Compressive Stress; Device Damaged by Another Device; Physical Resistance/Sticking; Stretched; Deformation Due to Compressive Stress; Device Damaged by Another Device; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT IT WAS UNCLEAR IF THE DISSECTION WAS CAUSED BY THE DEVICE, USER/TECHNIQUE ERROR, OR IF IT WAS PRE-EXISTING. THE DEVICES WERE PREPARED ACCORDING THE INSTRUCTIONS FOR USE (IFU). AS OF (B)(6) 2021 THE PATIENT WAS ALIVE AND STABLE.

  Patient problems: Vascular Dissection

  MAUDE report 11606676 ↗

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